Last Updated: September 24, 2026

Details for New Drug Application (NDA): 088496

✉ Email this page to a colleague

« Back to Dashboard

NDA 088496 describes HYDROXYZINE PAMOATE, which is a drug marketed by Barr, Barr Labs, Beximco Pharms Usa, Duramed Pharms Barr, Heritage Pharma, Impax Labs Inc, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Superpharm, Vangard, and Watson Labs, and is included in thirty-four NDAs. It is available from twenty-eight suppliers. Additional details are available on the HYDROXYZINE PAMOATE profile page.

The generic ingredient in HYDROXYZINE PAMOATE is hydroxyzine pamoate. There is one drug master file entry for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydroxyzine pamoate profile page.

Summary for 088496

Tradename:	HYDROXYZINE PAMOATE
Applicant:	Barr
Ingredient:	hydroxyzine pamoate
Patents:	0

Pharmacology for NDA: 088496

Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 088496

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	088496	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0323	0555-0323-02	100 CAPSULE in 1 BOTTLE (0555-0323-02)
HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	088496	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0323	0555-0323-04	500 CAPSULE in 1 BOTTLE (0555-0323-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG HYDROCHLORIDE
Approval Date:	Jun 15, 1984	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.